Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K202611
Catalyst OrthoScience R1 Reverse Shoulder System · Catalyst Orthoscience, Inc. · decided 2021-02-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| R1 Reverse Shoulder System | 1230-5213 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031350 |
| R1 Reverse Shoulder System | 1230-4292 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031237 |
| R1 Reverse Shoulder System | 1230-7507-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030537 |
| R1 Reverse Shoulder System | 1230-4224-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031169 |
| R1 Reverse Shoulder System | 1230-4213-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030964 |
| R1 Reverse Shoulder System | 1230-7511-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030599 |
| R1 Reverse Shoulder System | 1230-7503-004 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030438 |
| R1 Reverse Shoulder System | 1230-7502-002 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030391 |
| R1 Reverse Shoulder System | 1230-5209-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030803 |
| R1 Reverse Shoulder System | 1230-7516-002 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031268 |
| R1 Reverse Shoulder System | 1230-4211-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030926 |
| R1 Reverse Shoulder System | 1230-4225-002 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031190 |
| R1 Reverse Shoulder System | 1230-4242 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030858 |
| R1 Reverse Shoulder System | 1230-4202 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030766 |
| R1 Reverse Shoulder System | 1230-4264 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031114 |
| R1 Reverse Shoulder System | 1230-7508-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030544 |
| R1 Reverse Shoulder System | 1230-4203 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030773 |
| R1 Reverse Shoulder System | 1230-7513-002 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030698 |
| R1 Reverse Shoulder System | 1230-7511-003 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030612 |
| R1 Reverse Shoulder System | 1230-7504-003 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030469 |
| R1 Reverse Shoulder System | 1230-5202 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031060 |
| R1 Reverse Shoulder System | 1230-7511-002 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030605 |
| R1 Reverse Shoulder System | 1230-7506-001 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596030520 |
| R1 Reverse Shoulder System | 1230-4281 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031039 |
| R1 Reverse Shoulder System | 1230-7516-003 | CATALYST ORTHOSCIENCE INC. | PHX | 00811596031275 |